Membrane Sweeping in Early Labor and Delivery Outcomes
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|ClinicalTrials.gov Identifier: NCT03517696|
Recruitment Status : Withdrawn (Study IRB approval expired)
First Posted : May 7, 2018
Last Update Posted : September 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Early Labor||Procedure: Membrane sweeping||Not Applicable|
This is a non-blinded randomized controlled trial. Participants will be recruited at time of presentation to triage for labor evaluation after cervical exam. Patients with a term, singleton pregnancy who present with regular, painful contractions and a Bishop score < 7 will be recruited to the study. A random number generator will be used to create a list of random binary numbers. If the patient agrees to the study, the random number list will be used to assign the participant to membrane sweeping or no membrane sweeping. Participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise. Those not assigned to membrane sweeping will not have an additional exam. Patients will then be managed as per their primary Obstetrics (OB) provider with the exception of no further membrane sweeping throughout the labor course.
Participants are only required to participate during initial evaluation and randomization. No extra study visits are required.
Due to the nature of the intervention, which requires a provider to perform a procedure, blinding will not be possible for this trial.
No therapy will be withheld for any patients. Their labor course will be managed as per their primary provider using standards of care.
Non-treatment group is necessary in order to exam the difference of effects between membrane sweeping and no membrane sweeping.
Patients will be removed from the study if they chose to withdraw their participation.
Participants will resume care as normal regardless of withdrawing study participation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Non-blinded Randomized Controlled Trial|
|Masking:||None (Open Label)|
|Masking Description:||Intervention is not able to be blinded|
|Official Title:||Membrane Sweeping in Early Labor and Delivery Outcomes|
|Actual Study Start Date :||May 20, 2018|
|Actual Primary Completion Date :||February 25, 2020|
|Actual Study Completion Date :||February 25, 2020|
Active Comparator: Membrane Sweeping
Procedure: Membrane sweeping
Participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise.
No Intervention: Control
Routine vaginal exam
- Decrease in Cesarean delivery rate [ Time Frame: Up to 3 weeks ]Decrease in Cesarean delivery rate
- Time to delivery [ Time Frame: Up to 3 weeks ]Length of labor from randomization to delivery
- Operative vaginal delivery rate [ Time Frame: Up to 3 weeks ]Assess a decrease in operative vaginal delivery
- Labor augmentation rate reduction [ Time Frame: Up to 3 weeks ]Assess the reduction in the rate of labor augmentation ( via the use of oxytocin and/or amniotomy)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517696
|United States, Maryland|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Jeanne S Sheffield, MD||Johns Hopkins University|